User fee re-authorization fuels generics’ outlook

Generic Pharmaceutical Association president and CEO Ralph Neas called it “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act.” John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said the law served “the best interests of America’s patients.”

The enactment in July of the Prescription Drug User Fee Act, or PDUFA, which by law must be re-authorized every five years, provides the Food and Drug Administration with much of the funding the agency needs to review and approve manufacturers’ new-drug applications.

This year, for the first time, the law included Generic Drug User Fee Amendments, thus creating a system of user fees for generic drug companies. The fees, which are projected to raise about $299 million per year over five years, will go toward hiring extra staff to help clear the agency’s estimated backlog of 2,500 generic drug approval applications awaiting review.

The new funding also will spur development of bioengineered and biosimilar medicines by providing the FDA “with the resources necessary to help build new scientific and regulatory capabilities … and promote ongoing biopharmaceutical innovation,” according to Castellani.

Telemedicine, mhealth apps gain ground

New applications based on advances in telemedicine and mobile health technology are proliferating as pharmacy providers, physicians and health plans find new ways to connect with patients who are homebound or in remote locations. The result is to extend access to care, improve convenience and lower health delivery costs.

Drug chain innovators like Thrifty White have offered prescription dispensing and telemedicine services for years to reach patients far from a brick-and-mortar store with pharmacy services, using either a kiosk or a pharmacy technician linked in real time via a live monitor to a pharmacist at a “hub” location. More recently, advances in mobile health applications for computers, remote site kiosks and smartphones have extended the ability of pharmacies and other health providers to reach patients where they live and work.

This fall, telemedicine and mobile health, or mhealth, applications reached another crescendo. Walgreens’ Take Care Health Systems announced a new collaboration with Blue Cross and Blue Shield of North Carolina. Called OnlineCareNC, the new collaborative service allows BCBSNC members to receive a telehealth consultation from a Take Care nurse practitioner, health coach or nutritionist via two-way video, secure text chat or phone.

Almost simultaneously, two other technology providers expanded their own mobile health commitments. SoloHealth unveiled plans to expand its FDA-approved SoloHealth Station health-and-wellness digital kiosks to more than 2,500 store locations by mid-2013 on the way to more than 4,000 locations by 2014. And kiosk maker PharmaSmart said it was partnering with the U.S Centers for Disease Control and Prevention’s “Team Up. Pressure Down.” program to promote blood pressure management among patients with hypertension.

RxAlly offers powerful performance network

For decades, community pharmacy has waged a tireless campaign to gain recognition as an equal partner on the nation’s healthcare delivery team, and support for the role pharmacists can play as front-line patient care advocates. That campaign has become increasingly urgent as hospital and primary care costs go through the roof, payers seek lower-cost healthcare solutions and health reform shifts the focus from traditional modes of fee-for-service payment to a reimbursement system that rewards successful patient outcomes.

Pharmacists win that recognition every day within their communities as they provide accessible care and counseling for patients, and extend the framework of care initiated by family physicians, specialists or hospitals. But when more than 22,000 individual pharmacies band together to promote cost-effective, pharmacy-based care, that’s a powerful movement.

Such is the case with RxAlly, a unique, nationwide network of pharmacies focused on delivering personalized care to patients, lowering health costs and working within an integrated network of community care. The RxAlly Performance Network has gained new adherents and growing acceptance by arming its members with new tools to extend patient care and new programs to link those member pharmacies with the broader healthcare network within their communities.

“With more than 22,000 member pharmacies nationwide, RxAlly has brought together the largest national network of pharmacies to improve health and lower costs,” said CEO and chairman Bruce Roberts.

Led by founding member Walgreens, the nation’s top drug chain, RxAlly also numbers among its members many of the nation’s top regional chains and independents. “The launch of RxAlly represents a unique combination of the strengths of community pharmacies with the corporate resources of Walgreens,” said Doug Hoey, CEO of the National Community Pharmacists Association. “Health problems, such as the proper use of medications and the worsening primary care shortage, cry out for new solutions.”

Among recent moves, RxAlly’s network has developed a new, federally qualified Medicare Prescription Drug Plan, SmartD Rx. The new plan will be offered by its member pharmacies to the nation’s 46 million Medicare beneficiaries beginning in January 2013.

As part of a panel at the recent Drug Store News Industry Issues Summit, officials from Walmart and Kroger shared the ways the two organizations go about taking a collaborative approach to health care.

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